Clinical trials are key instruments in clinical research that enable the validation of research hypotheses, turning them into evidence that can be applied in standard clinical care. The population to be enrolled in a trial is typically described by a set of free-text eligibility criteria. The patients selected as eligible who agree to participate in a trial will be managed according to a detailed and rigorous trial protocol. This trial protocol is typically an extensive document describing, e.g., treatment steps with their timing, potential risks, adverse effects and their management, examinations and tests, and data collection.
Execution of a clinical trial involves obtaining and evaluating clinical data.
It is known to manage the collection of such clinical data during a clinical trial using Clinical Report Forms (CRFs) that specify the clinical data to be obtained throughout the trial and will be filled in for each patient by the treating clinical site with the measured values, such as demographics, diagnosis, lab values, scans, etc. At the clinical site that leads the trial, i.e., where the principal investigator is located, the CRFs are received from all participating clinical sites. As the trial progresses, the clinical data is stored in a Clinical Trial (CT) management system. The CT management system stores the collected clinical data in a structured form. The most advanced CT management systems also provide Electronic Data Capture, by providing electronic forms through which the CRFs are filled in.